Once-weekly HIV therapy may offer alternative to daily pills
Laine Bergeson, August 4, 2026
A once-weekly oral HIV treatment maintained viral suppression as effectively as a standard once-daily regimen in a phase 3 clinical trial, offering a potential new treatment option for people living with HIV.
The randomized, double-blind trial, published in the New England Journal of Medicine last week, looked at a once-weekly combination tablet containing islatravir and lenacapavir in adults whose HIV had remained suppressed for at least six months while taking the daily regimen bictegravir–emtricitabine–tenofovir alafenamide.
Stable immune cell counts
A team led by a researcher at University Hospital Bonn in Germany and including study-drug makers Merck and Gilead Sciences randomly assigned 607 adults at 106 sites in 12 countries to either switch to the weekly pill or continue their daily medication.
At week 48, no participants taking the once-weekly regimen had a viral load of 50 copies per milliliter or higher, compared with one participant (0.3%) in the daily-treatment group. Overall, 93.4% of participants taking the weekly regimen and 92.4% of those continuing daily therapy maintained viral suppression, signaling that the weekly treatment was noninferior to the standard daily regimen. None of the participants developed resistance to either islatravir or lenacapavir.
Levels of CD4+ T-cells and total lymphocytes, which are immune cells that help fight infections, remained stable in both groups. Earlier studies of higher daily doses of islatravir had raised concerns about declines in the number of immune cells.
Comparable safety profiles
Roughly 79% of participants in each group experienced at least one mild or moderate adverse event, such as headache or diarrhea. Serious adverse events were less common, occurring in 16 participants (5.3%) receiving the weekly regimen and 14 participants (4.6%) receiving daily therapy.
Six participants in the weekly regimen group and five in the daily regimen group discontinued treatment due to adverse events. No deaths were reported. “As such, these findings support the safety of the current weekly 2-mg [milligram] dose of islatravir,” write the researchers.
The first ever weekly oral therapy for the treatment of HIV could offer welcome relief from the burden of life-long daily pill-taking for people living with HIV.
The investigators say a once-weekly oral regimen could help address "pill fatigue," or the mental and emotional burden of taking medication every day. For some patients, a weekly oral regimen may be more convenient than long-acting injectable HIV therapies, which require regular clinic visits.
“The first ever weekly oral therapy for the treatment of HIV could offer welcome relief from the burden of life-long daily pill-taking for people living with HIV,” senior study officer Chloe Orkin, MBBCh, and professor of infection and inequities and dean for healthcare transformation at Queen Mary University of London, said in a university news release. “This is especially important for people that are experiencing stigma and people with other HIV-associated health conditions who are taking multiple other tablets.”
Contact:
Jim Wappes
jwappes@umn.edu
University of Minnesota
Source: CIDRAP - Center for Infectious Disease Research & Policy - University of Minnesota
https://www.cidrap.umn.edu/hivaids/once-weekly-hiv-therapy-may-offer-alternative-daily-pills
“Reproduced with permission - CIDRAP - Center for Infectious Disease Research & Policy - University of Minnesota”
CIDRAP - Center for Infectious Disease Research & Policy - University of Minnesota
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